Updating the Common Rule

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WASHINGTON -- Scientists and scholars have had no shortage of complaints about the impact that federal rules governing human research subjects have on their work. The elaborate review process involving institutional boards and federal panels has failed to keep pace with the explosion in federally supported research projects -- with the system spread so thin focusing on studies that pose little to no risk, critics argue, that it sometimes fails to pay sufficient attention to those that could significantly imperil participants.

Complaints have come particularly from those who work in social science and some humanities fields such as history and journalism, who say the burdensome process can slow their work to a crawl, even though it typically poses little threat to participants.

The federal government's first major review of its so-called Common Rule governing the protection of human research subjects, announced last month, has the potential to ease if not resolve many of the concerns of scholars, based on the early signs, say several experts on research policies, including several traditionally vocal critics.

While the advance notice of proposed rule making published by the Department of Health and Human Services last month leaves many thorny issues unresolved and raises some new concerns -- notably by proposing that all research studies at a university be subject to the Common Rule if any study at that institution is supported with federal funds -- the government's proposed approach and the process it has set in motion to approve it could be a "huge step forward," said C.K. Gunsalus, director of the National Center for Professional and Research Ethics, a research professor in the Coordinated Science Laboratory at the University of Illinois at Urbana-Champaign, and an Inside Higher Edcolumnist. "The spirit of this is right in line with everything I could have hoped for, and it also benefits from being written in regular human being words."

"If one assumes that the spirit of sharing in which they presented these initial thoughts is a signal about how they seek to have this process unfold, that’s a very positive way for HHS and its Office for Human Research Protections to kick off the process," added Felice J. Levine, executive director of the American Educational Research Association.

Common Complaints

The Common Rule has been the federal government's primary mechanism for protecting human participants in research studies for more than 20 years; it has been embraced by most federal agencies that sponsor research, and it strives to protect patients and other research subjects from harm without unnecessarily impeding scholars from doing their work.

How the government has struck that balance has ebbed and flowed a bit at times, particularly when concerns have arisen about patient safety (as after the 1999 death of a research subject at the University of Pennsylvania). But researchers have increasingly chafed at what they see as excessive (and unnecessary) regulation (by their campus institutional review boards) of studies in which there appears to be little or no potential risk to subjects, especially in the humanities and social and behavioral sciences. Groups like the American Historical Association have gone so far as to push for an exclusion for fields such as oral history.

The July 23 proposal notes that the revision of the rules is designed, first and foremost, to "better protect human subjects who are involved in research"; how could the government assert anything but that, given the regulations' purpose?

But in a long introductory section laying out the background for the proposed revision, the agencies acknowledge researchers' concerns about regulatory burden and overreach and the agencies' desire to do something about them. "The unnecessary burdens and workload carried by Institutional Review Board[s] (IRBs) is often cited," says an HHS FAQ about the proposal. "Certain regulatory requirements of government agencies could be clarified and streamlined. Moreover, the regulatory framework does not appropriately calibrate research review and does not focus the review where it is needed most."

After years in which they tended to rebuff researchers' criticism of human subject regulations by saying the rules were misunderstood, "finally, federal officials are actually conceding that there may be some problems in the regulations themselves," said Zachary Schrag, an associate professor of history at George Mason University and author of the Institutional Review Blog.

While it might seem contradictory that softening requirements in certain areas could in any way strengthen the protection of research subjects, that's not necessarily so, HHS officials seem to be saying. By focusing the process of reviewing research risks on those projects that pose the greatest potential risks -- in part by easing requirements for less-risky studies -- research subjects will be better off over all, the agency suggests. "If the risk-based framework for IRB review were more rationally refined," the FAQ says, "IRBs would be better able to concentrate their resources on the review of research that poses higher risk to subjects."

Several of the changes are specifically designed to "improve efficiency and remove burdens on investigators that do not, in the agency's view, meaningfully add to human subject protections," notes an analysis by the law firm McDermott Will & Emery. Among those are a proposal to "excuse" from IRB review studies posing risks that are largely "informational" (rather than physical) if they adhere to certain standards for data security.

In one of many questions that the proposal puts forward for discussion, HHS also suggests that studies using "educational tests, surveys, interviews, and similar procedures," when conducted with competent adults, could be excused from IRB review. For studies that fell into these and other excused categories, researchers would still be required to submit a one-page description of their research to an institutional review board, but that would be the extent of their interaction with the panels.

Another proposal would allow a single institutional review board to approve studies that are conducted at multiple sites, potentially alleviating the problem of researchers from multiple universities who collaborate on a project and get different (and sometimes conflicting) answers from their institutions' review boards about the project. The government's willingness to consider changes like that shows that they've "obviously paid attention to the concerns raised by the social and behavioral sciences about what constitutes minimal risk," said Levine of AERA.

Heartened as they are about changes that would simplify the review process for less-risky studies, several scholars said they were far less pleased by other HHS proposals, especially one that would extend federal research protections to all studies conducted at American universities or other institutions that receive some federal funding for human subjects research. The change is designed to respond to the concern raised by some consumer advocates that human subjects in privately funded research studies receive no protection; ethical problems have been identified, for instance, in research conducted at fertility clinics and other companies that do not receive federal funds.

That's a real problem, said Gunsalus, the Illinois researcher and ethics expert. But the solution proposed by the Department of Health and Human Services -- while "easier to administer" than other potential approaches -- would take "the wrong fork in the road," she said. "I have a hard time seeing how it makes sense to cover poets at universities but ignoring" surveys done by companies or research that takes place at fertility clinics or other entities that forgo federal funds. "I don't agree with this choice, and don't think it will solve the problem in the way they think it will."

Gunsalus said she would urge HHS to reconsider that change in the comment period that it is now beginning on the regulations -- a process designed to be a conversation, given the dozens of questions the agency has posed and on which it has sought advice. "I hope the research community will take advantage of the comment period to raise the issues that matter to them, and we can make this even better than it is at this point." The American Historical Association issued a similar call to action this week.

Schrag of George Mason agrees that the agency's invitation suggests a welcome openness to engage with scientists and scholars about the many issues and questions HHS has left unresolved. But he is concerned that the system the agency appears to be putting into place does not seem to offer "an ongoing process by which the experts could participate" in regularly updating the regulations that are eventually implemented.

The Common Rule has gone largely untouched since being adopted -- it was "codified in 1981, and just got stuck," Schrag said, despite significant technological and other developments that changed the research landscape. Canada, by comparison, enacted its only roughly similar system in 1998, revised it three times, and then rewrote it in 2010, he said.

"The tenor of the revision here is, 'We're going to make these changes and check back in 30 years,' " Schrag said. "That would be a mistake no matter how good the regulations are."